SP017 (EudraCT number 2016-000567-16)
Research type
Research Study
Full title
A phase I/II study of neoadjuvant dendritic cell immunotherapy (DCVAC/PCa) for organ-confined prostate cancer: tissue evaluation of immune infiltration into the primary tumours.
IRAS ID
201537
Contact name
Hardev Pandha
Contact email
Sponsor organisation
SOTIO a.s.
Eudract number
2016-000567-16
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Patients diagnosed with intermediate- and high-risk localised prostate cancer (prostate cancer localized to the prostate gland) are primarily treated with radical prostatectomy (RP, surgical removal of the prostate). Unfortunately, in a high number of these patients the disease eventually relapses. The main purpose of this study is to find out which cells of the immune system are present in the prostate tumour before and after treatment with the study drug. The study physicians also hope to learn if it is safe to use DCVAC/PCa before radical prostatectomy and how the reaction of the immune system changes after treatment with the study drug.
The investigational medicinal product (study drug) is called DCVAC/PCa. “Investigational” means that the drug has not yet been approved by the European Medicines Agency (EMA) or Medicines and Healthcare Products Regulatory Agency (MHRA) for treatment of prostate cancer. DCVAC/PCa is a cellular product which is made from patient‘s own cells, obtained after a special blood collection called leukapheresis. These cells are then treated and given back to the patient as a treatment for his cancer. We are investigating whether the study drug, if given before surgical removal of the prostate (radical prostatectomy), can improve the outlook after the surgery. This treatment is individualized as the study drug the patient will receive will have been made from his own cells.
This study will enrol up to 15 patients. The study population will consist of men with intermediate- and high-risk localized prostate cancer eligible to undergo radical prostatectomy. This is a single-arm (all patients will receive DCVAC/PCa), single-centre clinical trial. Each patient’s participation in the clinical trial is planned for approximately 18-20 weeks and will include following periods: Screening (this is done to find out if the patient can be enrolled in the study), Leukapheresis period, Treatment period, Radical prostatectomy.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1435
Date of REC Opinion
28 Sep 2016
REC opinion
Unfavourable Opinion